Efficacy of Favipiravir Against Severe Ebola Virus Disease
Açar sözlər
Mücərrəd
Təsvir
This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.
Tarixlər
| Son Doğrulandı: | 12/31/2015 |
| İlk təqdim: | 01/18/2016 |
| Təxmini qeydiyyat təqdim edildi: | 01/20/2016 |
| İlk Göndərmə: | 01/25/2016 |
| Son Yeniləmə Göndərildi: | 01/20/2016 |
| Son Yeniləmə Göndərildi: | 01/25/2016 |
| Həqiqi Təhsilin Başlama Tarixi: | 10/31/2014 |
| Təxmini İlkin Tamamlanma Tarixi: | 03/31/2015 |
| Təxmini İşin Tamamlanma Tarixi: | 04/30/2015 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Other: WHO-recommended therapies
Drug: Treatment
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Active Comparator: Control WHO-recommended therapies, mainly symptomatic and supportive treatments. Briefly: body fluid management (intravenous or oral, depending on patient status), balanced nutrition (including glucose, electrolytes, vitamin, et al.), preventing intravascular volume depletion, correcting profound electrolyte abnormalities, avoiding the complications of shock, defervesce, anti-diarrheal, acesodyne, anti-anxiety. For patients with positive Plasmodium detection or bacterial infection, apply artemether-lumefantrine or antibiotics respectively. Details refer to 'Manual for the care and management of patients in Ebola Care Units/Community Care Centres, Interim emergency guidance' and 'Clinical Management of Patients with Viral Haemorrhagic Fever: A Pocket Guide for the Front-line Health Worker' by WHO. | |
| Experimental: Treatment WHO-recommended therapies plus oral administration of Favipiravir | Drug: Treatment oral administration of Favipiravir tablets |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 13 Years Üçün 13 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Male or famale，13 -75 years of age - Clinical diagnosis of EVD - Positive blood viral RNA detection - With any one of the symptoms below: Hemorrhage (including hematemesis, hemoptysis, hematochezia, hematuria, mucocutaneous hemorrhage), severe dehydration (including oliguria, anuria, feebleness, hypotension, tachycardia), consciousness disorders (including coma, delirium, confusion, convulsion), shock, and high blood viral load (Ct value below 20) - Not received any therapies for EVD - Provided written informed consent, by guardian or the patient himself - Be able to administrate and tolerate oral administration of tablets Exclusion Criteria: - Severe vomiting - Pregnancy and breast-feeding - Received antiviral treatment against EVD |
Nəticə
İlkin nəticə tədbirləri
1. Case fatality rate [14 days]
İkincili Nəticə Tədbirləri
1. Blood viral load [1-3 days]
